I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

A Lack of Government Transparency: The Devil In The Detailing

A House Appropriations subcommittee has voted to move forward legislation that would cut $1.3 billion from the Department of Health and Human Services (HHS) and also eliminate all funding for the Agency for Healthcare Research and Quality (AHRQ). It would effectively eliminate not only all federal funding of patient-centered outcomes research, which is conducted by AHRQ, but also the agency’s dubious, non-transparent program of government-sponsored “academic detailing,” a program that owes its origins to the 2009 economic stimulus bill.

“Drug detailing,” which has sales reps from pharmaceutical companies visiting doctors’ offices to provide detailed information about their products, in the form of marketing materials and conversations, has been around for decades. Because many healthcare providers find it difficult to keep up with the newest therapies as they become available, this activity is a legitimate and sometimes valuable source of information. Not surprisingly, the information provided is intended primarily to stimulate sales of the products from the detailers’ own companies, regardless of whether more effective, safer or less expensive options exist. Because this commercial purpose supposedly hoodwinks doctors and makes them incapable of weighing the evidence for and against various treatments, the FDA imposes strict requirements on what representatives are permitted to tell physicians, and advertising and promotional materials must be approved by regulators.

As a further antidote to the inherent bias of drug detailing, the federal “academic detailing” program sends government employees who function as a sort of mirror image of drug company reps to doctors’ offices to offer a supposedly more disinterested viewpoint. This mechanism for providing “balance” sounds good in theory, but a glaring lack of transparency in the program makes it hard to know how it functions in practice. Agents of the government may be providing doctors with information about treatment alternatives that reflects biases of their own.

The government’s academic detailing program could serve to reduce government spending on healthcare, a laudable goal, but the program is plagued by the same sort of conflict of interest as drug detailers, just in reverse. The law exempts the feds from the same transparency standards applied to the drug industry.

The Agency for Healthcare Research and Quality, the agency responsible for academic detailing, has already let contracts and grants worth $12 million to public relations and physician outreach firms, and the program is slated to expand exponentially in the coming years. Yet in contrast to the onerous regulatory burdens on industry drug reps, AHRQ has conveniently excused itself from reporting which doctors it contacts or what they are being told, citing as its rationale a privacy law that Congress intended to protect patients (but not doctors). Congress should clarify that AHRQ may disclose which doctors they are approaching and require the reporting of this information both to FDA and to the public, just as pharmaceutical companies must.

Leaving aside the broader question of whether the government should pay PR firms to influence doctors in the first place, doing so in secret is pernicious. Academic detailers focused primarily on cost-cutting may be tempted to gloss over the fact that less expensive treatment options that are effective for most patients often won’t work for some of them. This is not merely a hypothetical concern. The initial academic detailing grants are intended to disseminate the findings of comparative effectiveness research (CER), which evaluates treatment outcomes derived from large-population — as opposed to patient-specific — data. This approach can be harmful to patients who don’t respond to medicine in the same way as a majority of patients.

For many classes of drugs — among them statins, anti-hypertensives, analgesics and antipsychotic medicines — the selection of the appropriate drug among many possibilities requires a delicate balancing of effectiveness and acceptable side effects in each patient. An example is the FDA’s 2009 approval of pitavastatin, a new drug to control cholesterol. One might question why we needed yet another statin as recently as a few years ago, but because of the way that pitavastatin is metabolized, it does not manifest the same dangerous interactions as other statins with drugs like the popular blood thinner warfarin (Coumadin). Therefore, it is especially useful for patients who take multiple other medicines.

Do government-funded detailers take such phenomena into account? Do they explain these nuances to doctors, or do they simply advise them to prescribe the least expensive medicines even if they don’t work well for some patients? Unless Congress fixes the law and the administration begins to reveal the details of its detailing, we may never know.

Another problem with the current lack of transparency is that we don’t know how the academic detailers are compensated – on straight salary or according to their success in getting doctors to prescribe cheaper therapies. We need to be informed about the government detailers’ possible conflicts of interest and whether they are presenting CER findings in a responsible, balanced way. One thing we do know is that doctors are enticed into the government programs by the promise of free continuing medical education credit — at taxpayer expense.

As long as federal officials are pursuing the dual goals of exerting influence over the prescribing habits of medical professionals and reducing healthcare costs, they should acknowledge that therein lurks a potential conflict of interest. And in their dealings with doctors, the government’s agents should have to abide by the same degree of scientific oversight and transparency standards demanded of others.

Henry I. Miller is a physician and fellow at Stanford University‘s Hoover Institution and the Competitive Enterprise Institute; he was an official at the NIH and FDA from 1977 to 1994. Jeff Stier, J.D., is a senior fellow at the National Center for Public Policy Research.

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